At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company.
Our open and progressive culture is what makes us Astellas.
It's a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force.
We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action.
We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity: The QC (Quality Control) Biochemist will be responsible for supporting operations through completion of all testing required e.g., receipt, in-process, finished and stability product testing, report writing, writing procedures, management of systems and training.
The role will also have responsibility for tasks associated with analytical method validation (technical transfer and pharmacopeial method validation).
Responsibilities: Perform tasks in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), ensuring safety compliance in the laboratory and facility.Manage analytical technical transfers, qualification of Pharmacopeial methods, and laboratory instrumentation qualifications.Oversee product testing, trend reports, and all associated activities; troubleshoot instruments and write reports/procedures.Train personnel on biochemical testing processes and document results in LIMS, ensuring peer review.Handle incident reports, non-conformances, CAPAs, OOS investigations, and lead QC process improvement projects.Author and update laboratory policies, procedures, and data trending, including Continuous Process Verification.Proficient in laboratory technologies including LIMS, SAP, Empower, and TrackWise.Extensive experience with instrumentation such as icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.Solid understanding and experience in completing Pharmacopeial testing.Education: B.S.
degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab or equivalent.Additional information: This is a permanent, full-time position.Position is based in Tralee – Ireland.This position requires you to be 100% on-site/in the office.We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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